Biogen and Elan on monday said they have submitted new safety data to U.S. regulators on their drug Tysabri, in hopes of getting the withdrawn multiple sclerosis treatment back on the market.more... Reuters.comBiogen Idec Inc. (BIIB.O: Quote, Profile, Research) and Elan Corp. (ELN.N: Quote, Profile, Research) on Monday said they have submitted new safety data to U.S. regulators on their drug Tysabri, in hopes of getting the withdrawn multiple sclerosis treatment back on the market.
The companies, which withdrew the injectable medicine in February, said they have asked the U.S. Food and Drug Administration to review the additional safety data within the next six months. That compares with the standard review period of 10 months.
Biogen Idec and Irish drugmaker Elan voluntarily suspended sales of Tysabri after one multiple sclerosis patient died following treatment with it in combination with Biogen Idec's widely used Avonex drug.
The patient died from a brain disorder known as progressive multifocal leukoencephalopathy (PML) and another patient at the time was suspected of having the condition, which is caused by a virus. Another case was identified in March, and two of the three patients have died.
The appearance of the rare disorder raised the question of whether Tysabri was making patients more susceptible to the so-called JV virus which causes it.
The drug was deemed a potential blockbuster when it was launched in November 2004 because clinical data suggested it was far more effective than existing treatments for multiple sclerosis, including Avonex.
The new data involves more than 3,000 patients with multiple sclerosis, Crohn's disease and rheumatoid arthritis that have taken Tysabri in past trials.
Some patients in the two late-stage multiple sclerosis trials took Tysabri by itself, while others took it in combination with Avonex.